The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease

NCT ID: NCT05924919

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-03-19

Brief Summary

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The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.

Detailed Description

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Arm: Whole-body Passive Heat Therapy (HT)

Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.

Group Type EXPERIMENTAL

Whole-body Passive Heat Therapy (HT)

Intervention Type PROCEDURE

The whole-body passive heat therapy (HT) intervention will consist of an acute bout of infrared sauna for 25 minutes at 60°C. Participants will lie supine on a memory foam pad.

Thermoneutral Control (CON)

Intervention Type PROCEDURE

Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes.

Interventions

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Whole-body Passive Heat Therapy (HT)

The whole-body passive heat therapy (HT) intervention will consist of an acute bout of infrared sauna for 25 minutes at 60°C. Participants will lie supine on a memory foam pad.

Intervention Type PROCEDURE

Thermoneutral Control (CON)

Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* Stage 2-4 CKD

Exclusion Criteria

* Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes
* Uncontrolled hypertension
* Current fluid restrictions
* End stage kidney disease or currently on dialysis treatment
* Body weight \< 40kg
* Exhibits any contraindications to exercise as per ACSM guidelines
* Regular tobacco and/or nicotine use
* History of heat-related illness
* Participates in regular exercise and/or sauna use
* Current hormone replacement therapy
* Pacemaker or electro-medical implant
* Persons with or at risk of intestinal disorders including gastroporesis
* History of diverticula
* Persons who have undergone surgical procedures in the GI tract
* Swallowing disorders
* Chron's disease
* Current pregnancy
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Kirkman, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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22-01741

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20024906

Identifier Type: -

Identifier Source: org_study_id

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